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POTASSIUM PHOSPHATES Drug Patent Profile

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When do Potassium Phosphates patents expire, and when can generic versions of Potassium Phosphates launch?

Potassium Phosphates is a drug marketed by Am Regent, Amneal, Cmp Dev Llc, and Fresenius Kabi Usa. and is included in four NDAs. There is one patent protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in POTASSIUM PHOSPHATES is potassium phosphate, dibasic; potassium phosphate, monobasic. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium phosphate, dibasic; potassium phosphate, monobasic profile page.

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Summary for POTASSIUM PHOSPHATES

International Patents:	1
US Patents:	1
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	4
Clinical Trials:	1
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in POTASSIUM PHOSPHATES?	POTASSIUM PHOSPHATES excipients list
DailyMed Link:	POTASSIUM PHOSPHATES at DailyMed

Drug patent expirations by year for POTASSIUM PHOSPHATES

Recent Clinical Trials for POTASSIUM PHOSPHATES

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mahidol University	N/A

See all POTASSIUM PHOSPHATES clinical trials

Pharmacology for POTASSIUM PHOSPHATES

Drug Class	Osmotic Laxative Potassium Salt
Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

US Patents and Regulatory Information for POTASSIUM PHOSPHATES

POTASSIUM PHOSPHATES is protected by one US patents and two FDA Regulatory Exclusivities.

Patents protecting POTASSIUM PHOSPHATES

Potassium phosphates composition for injection
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: POTASSIUM PHOSPHATES INJECTION IS INDICATED AS A SOURCE OF PHOSPHORUS IN INTRAVENOUS FLUIDS TO CORRECT HYPOPHOSPHATEMIA IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

FDA Regulatory Exclusivity protecting POTASSIUM PHOSPHATES

COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216274-001	Oct 2, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cmp Dev Llc	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	212121-001	Sep 19, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Amneal	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216344-001	Oct 10, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	212832-001	Nov 26, 2019	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216274-002	Oct 2, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	POTASSIUM PHOSPHATES	potassium phosphate, dibasic; potassium phosphate, monobasic	SOLUTION;INTRAVENOUS	216274-003	Oct 2, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for POTASSIUM PHOSPHATES

See the table below for patents covering POTASSIUM PHOSPHATES around the world.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020081118		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for POTASSIUM PHOSPHATES

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0733366	SPC/GB98/031	United Kingdom	⤷ Sign Up	PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
3141251	301099	Netherlands	⤷ Sign Up	PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
1718641	SPC/GB12/028	United Kingdom	⤷ Sign Up	PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
1499331	13C0055	France	⤷ Sign Up	PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
0480717	98C0025	Belgium	⤷ Sign Up	PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0253310	SPC/GB95/010	United Kingdom	⤷ Sign Up	PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description